healthClass IIRecalled on Sep 17, 2025

Atellica CH Urinary/Cerebrospinal Fluid Protein (UCFP). Material Number: 11097543.

🔢 11,811 units

Sold At: Siemens Healthcare Diagnostics, Inc.(Worldwide distribution - US Nationwide and the countries of Argentina, Australia, Austria, Bahamas, Bahrain, Bangladesh, Belgium, Brazil, Bulgaria, Canada, Chile, China, Colombia, Croatia, Cura¿ao,¿St¿Eus, Czech¿Republic, Denmark, Egypt, Estonia, Ethiopia, Finland, France, Georgia, Germany, Greece, Hong Kong, Hungary, India, Indonesia, Ireland, Israel, Italy, Japan, Jordan, Kuwait, Latvia, Macedonia, Malaysia, Maldives, Mexico, Nepal, Netherlands, New Zealand, Norway, Oman, Pakistan, Paraguay, Peru, Philippines, Poland, Portugal, Qatar, Romania, Saudi Arabia, Serbia, Singapore, Slovakia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Tunisia, Turkey, Turkmenistan, U.A.E., United¿Kingdom, Uruguay, Vatikancity, Vietnam, Zaire.)

Recall #: FDA-DEVICE-Z-2542-2025

Source: FDA-ENFORCEMENT

Atellica CH Urinary/Cerebrospinal Fluid Protein (UCFP). Material Number: 11097543.

Product Identification

Lot/Batch Codes:
Material Number: 11097543. Test Code: UCFP. UDI-DI: 00630414279206. All lot numbers.

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Summary

Potential for falsely depressed patient, quality control (QC), and/or calibration results or delayed results.

What to do next

  • 1Stop using this product - may cause temporary or medically reversible health problems
  • 2Check with retailer or manufacturer for recall status and remedy options
  • 3Contact Siemens Healthcare Diagnostics, Inc. for return or refund information
  • 4Visit the official FDA recall page for complete details

Summaries only; always follow the official notice.